# K121125: Flexstent Biliary Self-Expanding Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Flexible Stenting Solutions, Inc.
- Decided: Jul 6, 2012 after 84 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 1, 2021 · Class II · Z-0219-2022: There is a potential for distal tip dislodgement or separation.
- Oct 1, 2021 · Class II · Z-0220-2022: There is a potential for distal tip dislodgement or separation.
- Oct 1, 2021 · Class II · Z-0216-2022: There is a potential for distal tip dislodgement or separation.
- Oct 1, 2021 · Class II · Z-0217-2022: There is a potential for distal tip dislodgement or separation.
- Oct 1, 2021 · Class II · Z-0218-2022: There is a potential for distal tip dislodgement or separation.
- Oct 1, 2021 · Class II · Z-0221-2022: There is a potential for distal tip dislodgement or separation.
- Nov 15, 2017 · Class II · Z-0324-2018: Potential for cracked luer hubs

## Indications for use
The FlexStent® Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K121125
Methodology: https://510kreport.com/methodology